FDA grants Pfizer expanded approval for Ibrance in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance...
FDA publishes a report summarizing demographic information from pivotal trials supporting 46 novel new drugs approved in 2025.
FDA sends Achieve Life Sciences a Complete Response Letter on its NDA for cytisinicline as a treatment for nicotine dependence.
FDA releases the form FDA-483 with two observations from an inspection at the Pharmaneek non-sterile drug manufacturing facility in Indianapolis, IN.
FDA closes a potential enforcement action against Whoop Inc., reversing an earlier regulatory position that raised questions about whether the company...
Drug company executives recommend ways FDA could increase the use of real-world evidence in regulatory decisions.
FDA warns South Koreas Huons Co. about CGMP violations in its manufacturing of finished drugs.
